SmB café 16 May '13 - CHDR - Wolf Ondracek

Science meets Business in Drug Development

CHDR: Unlocking the true potential…

• Established in 1987 as a not-for-profit foundation• By Leiden University and LUMC

• Prof. Douwe Breimer & Prof. Adam Cohen

• Clinical research organization closely linked to top level universities

• Profits re-invested in biomarker and method development & education

• Contract Research for bio-pharmaceutical industry• Focus on early phase clinical trials

• Data intensive, small number of subjects

• Proof of pharmacology

• Proof of concept

• Organization• 160 employees (80 FTE)

• Dynamic & International environment

• Wolf Ondracek, Director Business Development

Market positioning: A unique dual focus

Research areas

Cardiovascular System &

Metabolism

Respiratory System&Immuno-

inflammation

Central Nervous System

OncologyFood &

Nutraceuticals

PK/PD modeling

First-in-humans

Research in Children

Micro-dose studies

CHDR, among others, offers substantial experience with:• First-in-human studies in

healthy volunteers & patients

• Research in special populations such as young & elderly patients

• Research in patients with hepatic and/or renal impairment or patients from different ethnicity

• Thorough QT-studies, and bioequivalence experiments

Study Types

Innovative Tools for ‘Proof-of-Pharmacological-Concept’ Studies

• Continuous CSF-Sampling – CNS-drug concentrations– τ /ß-profiles, etc

• NeuroCart– multidimensional CNS-pharmacodynamics– optimized for CNS-drug effects and PK/PD– applicable in patients

• Neuroimaging– resting state fMRI– PET-imaging

Innovative Tools for CNS Studies: NeuroCart

• Cognitive and memory testing• Electroencephalography• Saccadic and smooth pursuit eye movement • Adaptive tracking • Finger tapping• Body sway• Visual analogue scales• Psychometric questionnaires• Autonomic function tests (pupillometry, heart rate

variability)• Polysomnography• Other CNS function tests like Symbol Digit

Substitution Test, Critical Flicker Fusion, Stroop conflict task, etc

Innovative Tools for CNS Studies: NeuroCartFeatures NeuroCart

-scope -neurocognitive functions included*, but also all other drug-responsive domains (neurophysiological, neuroendocrine, motor, subjective, etc)

-clinical relevance -functional validity for large number of individual functions: postural stability, eye-hand coordination, attention, subjective, etc

-interpretability -simple because each test mainly assess single brain function

-frequent repeatability -up to 10 times/day or more

-learning/carry-over effects -limited/absent

-dose/concentration responsiveness -extensive PK/PD-relations possible

-experience -extensive across large number of different drugs, accumulated within same CRO (CHDR)

Innovative Tools for CNS Studies: NeuroCart

• Electrical Stimulation– Olofsen and Dahan, 2005

• Pneumatic Pressure – Polianskis, 2001

• Cold Pressor– Eckhardt et al. 1998 and Jones et al. 1988

• Thermal stimulation– Medoc

• Hyperalgesia models– UV-B– capsaicin– thermal grill

Innovative Tools for Pain Studies: PainCart

Research Collaboration agreements with:

• Leiden University Medical Center, Leiden• Free University Medical Center, Amsterdam• Alzheimer Research Center, Amsterdam• Academic Medical Center, Amsterdam• Erasmus Medical Center, Rotterdam

Collaborations: National Collaborations

• Collaboration agreements with:• Seoul National University Hospital• Kyungpook National University Hospital• Peking Union Medical College• Showa University Hospital Tokyo• Melbourne• Edinburgh• University of Bucharest

• Data management system (Promasys)• Used at >30 locations worldwide• Including in Korea

• Seoul National University Hospital• Yonsei University Hospital• Samsung Medical Center• ASAN Medical Center• Kyungpook National University Hospital• Inje University Pusan Paik Hospital

• Teaching Resource Center for Clinical Pharmacology

Collaborations: International Collaborations

Collaborations: Our Customers

Collaborations: Our Customers

Unlocking the true potential